Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

NCT00041249 | Completed Phase 2

• 1 other identifier: EORTC-62011
• Study Type: interventional
• Target: 64
• Locations: 5 countries
• Sites: 16

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.

Conditions

Gastrointestinal Stromal Tumor; Sarcoma

Keywords

adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult rhabdomyosarcoma; gastrointestinal stromal tumor; stage IV adult soft tissue sarcoma

Interventions

brostallicin DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent * Stratum I * Malignant fibrous histiocytoma * Liposarcoma * Rhabdomyosarcoma * Synovial sarcoma * Malignant paraganglioma * Fibrosarcoma * Leiomyosarcoma * Angiosarcoma including hemangiopericytoma * Malignant peripheral nerve sheath tumor * Unclassified sarcoma * Miscellaneous sarcoma * Stratum II * Gastrointestinal stromal tumor * Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression * The following sarcoma types are excluded: * Mixed mesodermal tumors of the uterus (and carcinosarcoma) * Chondrosarcoma * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Ewing's sarcoma * Embryonal rhabdomyosarcoma * At least one measurable lesion * Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease * Clinical evidence of progression within 6 weeks prior to study treatment * No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age: * Over 15 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * SGPT and SGOT no greater than 3 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance greater than 65 mL/min Cardiovascular: * No prior severe cardiovascular disease Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 6 months after study * No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No other severe medical illness * No psychosis PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic response modifiers or immunotherapy * No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF) Chemotherapy: * See Disease Characteristics * More than 4 weeks since prior chemotherapy and recovered * Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy * No prior ecteinascidin 743 (stratum I) * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy * No prior radiotherapy to sole measurable lesion * Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No other concurrent anticancer therapy (approved or investigational) * No concurrent participation in any other clinical treatment study * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (16)

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Leon Berard

Lyon, 69008, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Robert Roessle Klinik

Berlin, D-13122, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

Munich, D-81377, Germany

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus University Medical Center

Rotterdam, 3008 AE, Netherlands

Location

St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden NHS Trust - London

London, England, SW3 6JJ, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Related Publications (2)

• Leahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Jan;43(2):308-15. doi: 10.1016/j.ejca.2006.09.014. Epub 2006 Nov 13.

  PMID: 17095209 RESULT

• Leahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003.

  RESULT

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Neurofibrosarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant; Rhabdomyosarcoma

Interventions

brostallicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma; Myosarcoma

Study Officials

• Michael Leahy, MBChB, FRACP, FRCP, FRC Path

  Fremantle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: January 1, 2004
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

DE (4); GB (3); BE (2); FR (3); NL (4)